FDA 510(k)

VIVO

K 號：K200313 · 2020-09-14

決定日期2020-09-14

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

VIVO is the device name listed in this FDA 510(k) record. The listed applicant is Catheter Precision, Inc.. It received FDA 510(k) clearance on 2020-09-14 under 510(k) number K200313. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VIVO?

VIVO is a medical device that received FDA 510(k) clearance on 2020-09-14. The listed applicant is Catheter Precision, Inc.. The 510(k) number is K200313.

When did VIVO receive FDA 510(k) clearance?

VIVO received FDA 510(k) clearance on 2020-09-14, under 510(k) number K200313.

Who is the listed applicant for VIVO?

The FDA 510(k) record lists Catheter Precision, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIVO?

The FDA product code for VIVO is DQK.

其他以 Catheter Precision, Inc. 為申請人之記錄

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K183195VIVO

相關器械（代碼：DQK）

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官方來源

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